InjuryKNP
DR COMFORT
Received Sep 10, 2024 · Event occurred Aug 13, 2024
Report 3008579854-2024-00004 · MDR key 20186454
Device
Generic name
Annie Black 9 Wide
Manufacturer
Dr Comfort; A Djo, Llc CompanyCatalog number
4510-W-09.0
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Pressure Sore/Ulcer
- Tissue Breakdown
- Pressure Sore/Ulcer
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT DEVELOPED A PRESSURE WOUND SHOE WHILE WEARING THE SHOE THE PRODUCT WA NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A PRESSURE WOUND SHOE WHILE WEARING THE SHOE.